What You Need to Know About Pre-market Tobacco Applications (PMTA)

The Family Smoking Prevention & Tobacco Control Act has made it mandatory for all new tobacco products to receive a premarket tobacco application (PMTA) authorization (license) before it can be sold in the U.S. market. Any product without a PMTA approval cannot be legally sold in the United States and is considered “adulterated” or “illicit” under federal statute. Believe it or not, the FDA and economic advisers to President Barack Obama at the time feared that quickly implementing the new tobacco regulations would result in catastrophe for a blossoming vaping industry.

As part of the new development, the FDA established a deadline of August 8, 2018, for manufacturers to submit premarket authorization applications for new tobacco products that were introduced into the market as of August 8, 2016 (products that had not been on the market as of that date could no longer be sold without receiving FDA market approval). In May 2017, the FDA proposed to extend the submission deadline by three months. Then, in July 2017, the agency announced its intention to extend this deadline even further, to August 8, 2021, for combustible products (e.g., cigars) and August 8, 2022, for non-combustible products like e-cigarettes. (In March 2019, the FDA published a draft compliance policy to move enforcement dates for flavored ENDS to August 8, 2021.)

How PMTA will affect vapers

After September 9, 2020, you won’t be able to purchase any products for which premarket authorization applications have not been submitted. Keep in mind that because the PMTA process is rigorous and expensive, many smaller manufacturers may choose not to file applications at all, whereas other companies may submit applications for only one or two products. And even if a manufacturer applies, there is no guarantee that the FDA will approve it, so some companies will decide that the risk is not worth the potential reward.

The future for vapers

If there’s one sure thing, it’s that the vaping industry will never be the same. The unprecedented lawsuit leaves all manufacturer futures in the air. If manufacturers had a PMTA plan, they surely had to throw it out with two years less to execute it. And even if companies file before the deadline, there’s no telling how long it will take for them to get an approval or denial on their application.

There is no concrete information about applications that get submitted after the deadline passes. If the applications are even accepted, they have to wait for every other manufacturer in the queue to await their product’s fate. A product that is available right now may not be available in a year due to the application’s processing deadline.

My best advice is to stock up on your favorite flavors especially if you don’t know how to DIY vape juice. That way you will still get some of your favorite flavors around for some time.

With a dream to lead the vaping market with creative, innovative breakthroughs, Vaporesso is fully committed to the current PMTA process and are confident in the content and quality of the materials they have submitted with their application.

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